Vascular Solutions (NSDQ:VASC) said today that it filed an investigational new drug application with the FDA for the RePlas freeze-dried plasma product it’s developing with the U.S. Army Medical Material Development Activity. RePlas is an easily transported, freeze-dried alternative to fresh frozen plasma, which requires freezing and a lengthy thawing process before it’s ready to use. According to the development […]
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Vascular Solutions recalls Twin-Pass dual access caths
Vascular Solutions (NSDQ:VASC) said yesterday it initiated a nationwide recall of its Twin-Pass dual access catheters due to a potential for excess material in the catheter that could dislodge and pose a risk for embolism. The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse […]
Vascular Solutions shares soar, raises guidance on Q2 earnings release
Vascular Solutions (NSDQ:VASC) saw shares soar after releasing 2nd quarter earnings that beat the Street and significantly grew from last year. The Minneapolis, Minn.-based company reported profits of $5.4 million, or 31¢ per share, on sales of $5.4 million for the 3 months ended June 30. That amounts to a massive 45% bottom-line gain as […]
The legalization of off-label promotion: Vascular Solutions beat the FDA and what their victory means for medtech
Welcome to the Medsider interview series, a special new feature at MassDevice, which will appear regularly. All interviews are conducted by Scott Nelson, Founder of Medsider. We hope you enjoy them! For as long as I can remember, at every company meeting I’ve ever been to, the topic of off-label promotion is always covered. Whether it […]
Vascular Solutions initiates voluntary recall of Guardian II valve
Vascular Solutions (NSDQ:VASC) said today it initiated a recall of its Guardian II hemostasis valves designed for use in catheterization procedures over an increased risk of air leakage that could lead to air embolism. The Minneapolis, Minn.-based company said the FDA labeled the recall as a Class I, the agency’s most serious classification of recall, which is used […]
The exodus of key personnel at Google’s Verily | Personnel Moves for March 29, 2016
There’s reportedly a rare exodus under way of key personnel from a Google (NSDQ:GOOG) operation, its Verily healthcare “moonshot,” with former employees blaming the mercurial leadership of CEO Andrew Conrad. A dozen top engineers, scientists and managers have departed since Verily, formerly Google Life Sciences, was launched 3 years ago, according to the Stat website. […]
Icahn claims success, steps back from Hologic | Personnel Moves
Billionaire investor Carl Icahn said last Friday that he will begin to ramp down his involvement with Hologic (NSDQ:HOLX), claiming his intervention with the company to be a success. As part of the stepping away process, Icahn representatives Jonathan Christodoro and Samuel Merksamer stepped down from the board and will not be replaced, according to SEC […]
Vascular Solutions, CEO Root beat criminal charges in off-label promotion case
A federal jury last week acquitted Vascular Solutions (NSDQ:VASC) and CEO Howard Root of charges that they ran an off-label promotion scheme for its now-discontinued Vari-Lase varicose vein treatment. A grand jury in the U.S. District Court for Western Texas indicted Maple Grove, Minn.-based Vascular Solutions and Root in November 2014, alleging that they created a “Short Kit” version of […]
Vascular Solutions droops on Q4, FY2015 earnings
Vascular Solutions (NSDQ:VASC) shares drooped over 10% after releasing a mixed bag of Q4 and its 2015 fiscal year earnings, beating the street for quarterly EPS and revenue, but missing for FY2015. Minneapolis, Minn.-based Vascular solutions reported profits of $1.6 million, or 9¢ per share, on revenue of $38.1 million for the 3 months ended December […]
Clearpath Robotics snags Intuitive Surgical design guru Hanuschik | Personnel Moves
Self-driving vehicle development company Clearpath Robotics said today it picked up Intuitive Surgical‘s (NSDQ:ISRG) director of design & management Mike Hanuschik. Hanuschik led the design and product management for Intuitive Surgical’s flagship da Vinci surgical robot system, the market leading robotic surgery platform. The da Vinci is used in over 500,000 procedures annually, according to […]
New JenaValve CEO is Boston Scientific vet Carr-Brendel | Personnel Moves
JenaValve said this week that it tapped Victoria Carr-Brendel, former general manager of Boston Scientific‘s (NYSE:BSX) Bayer Interventional business, as its new chief executive officer. Carr-Brendel will replace Jan Keltjens, who served as interim CEO of the transcatheter aortic valve repair-focused company since January 2015. Keltjens will remain with the company as chairman of the board, JenaValve said. […]